Senior Clinical Study Manager - Early Phase

Job Summary As the Senior Clinical Study Manager, you will play a crucial role in overseeing and managing Otsuka’s clinical studies, ensuring effective coordination with various departments and external service providers. Your responsibilities will encompass the planning, execution, and completion of clinical trials that comply with all relevant regulations, including ICH Guidelines, Good Clinical Practices (GCP), and Otsuka Standard Operating Procedures (SOPs), within set timelines and budgets. Key Responsibilities Oversee clinical studies at Otsuka, ensuring compliance with applicable regulations, ICH/GCP, and Otsuka SOPs throughout the study lifecycle. Contribute to the development and review of all essential clinical study documents, including protocols and informed consent forms. Assist in the identification, evaluation, and selection of Contract Research Organizations (CROs), external vendors, and investigative sites. Provide leadership and guidance to the clinical team, ensuring all study activities align with regulatory requirements and internal standards. Enhance communication and coordination across all relevant departments regarding clinical project activities and progress. Report timely updates on project progress, scope changes, schedules, and resource allocations to management. Assist in forecasting study expenditures and resource requirements. Ensure internal teams and vendors effectively manage and monitor study budgets and expenses. Communicate any budget variances promptly to leadership. Establish effective communication channels with CROs and investigative sites to ensure protocol compliance. Oversee external service providers managing daily operations of assigned trials. Participate in the ongoing review of clinical trial data, focusing on integrity and consistency. Support inspection readiness initiatives, ensuring the quality and completeness of the Trial Master File (TMF). Represent Clinical Management in protocol reviews across various portfolios as needed. Engage in program-level risk mitigation strategies and collaborate on study-level risk management activities. Participate in cross-functional initiatives as the Clinical Management representative. Lead and contribute to efforts aimed at departmental standardization and continuous improvement. May oversee training and onboarding of new employees, ensuring compliance with policies and adequate resource availability. Provide feedback and establish performance expectations for team members. Qualifications Required: Bachelor's Degree or equivalent experience as a Registered Nurse (RN). Minimum of 10 years of industry experience, including 7 years specifically in clinical trial management. Preferred: Previous supervisory experience. Skills and Competencies Strong knowledge of clinical operations, drug development processes, and applicable SOPs and regulations. Understanding of CROs and vendor relationships. Excellent communication, organizational, planning, analytical, problem-solving, and people management skills. Proficient in Microsoft Office suite and clinical trial-related software. Able to travel up to 25% as needed. We offer a competitive salary ranging from $150,034 to $224,250, along with an incentive opportunity, reflecting the skill set and experience of the chosen candidate. Otsuka provides comprehensive benefits including medical, dental, vision, disability insurance, and a robust 401(k) matching program, among others. For more details about our offerings and to learn more about Otsuka, please visit our careers page. Disclaimer: This job description provides a brief overview of the typical tasks associated with this position. Otsuka may amend responsibilities as needed to meet business requirements. Otsuka is an equal opportunity employer and encourages all qualified applicants to apply, regardless of any protected characteristic. If you require accommodations due to a disability or are a disabled veteran, please reach out for assistance in the application process. Otsuka prioritizes your privacy and security. We do not request personal financial information during the hiring process and advise caution against fraudulent job offers.

Created: 2026-03-10